BEUDAMED
    FDA Adverse Event Other Summary report: N

    CHALGREN

    MDR report key: 1781438 · Received July 30, 2010

    Report

    Report Number
    2939713-2010-00001
    Event Type
    Other
    Date Received
    July 30, 2010
    Date of Event
    April 2, 2007
    Report Date
    July 29, 2010
    Manufacturer
    CHALGREN ENTERPRISES, INC
    Product Code
    IKT
    PMA / PMN Number
    K912283
    Removal / Correction Number
    K912283-4/12/07-001R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FDA AUDITOR, (B)(4) OBTAINED SEVERAL RELATED DOCUMENTS FROM CHALGREN. ALSO THE INCIDENT WAS REPORTED TO (B)(4) BRANCH OF THE FDA. MR. (B)(4) INDICATED HE WOULD CONTACT CHALGREN IF FURTHER INFO IS NEEDED.

    Description of Event or Problem · 1

    SOME TYVEK POUCHES HAD INADEQUATE SEALS COMPROMISING STERILE INTEGRITY. THIS AFFECTED PRODUCT 110-725, LOT #P059, MANUFACTURED 04/11/2006 AND EXPIRED 04/2009. PRODUCT WAS REMOVED FROM MFR'S INVENTORY AND ALSO REMOVED FROM THE MARKETPLACE. A CORRECTIONS AND REMOVALS RECORD WAS GENERATED BY CHALGREN. HOWEVER, DURING A RECENT AUDIT IT WAS DETERMINED THAT AN MDR SHOULD HAVE BEEN REPORTED AND THAT A RECALL, NOT CORRECTIONS AND REMOVAL SHOULD HAVE TAKEN PLACE. THE INCIDENT WAS RECORDED ON COMPLAINT RECORD (B)(4) AND THE PRODUCT NONCONFORMITY WAS TRACKED ON (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHALGREN EMG ELECTRODE IKT CHALGREN ENTERPRISES, INC 110-725 P059

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention